Deploying POKE Within Intermountain Healthcare (POKE)

September 26, 2018 updated by: Intermountain Health Care, Inc.
To assess the impact of POKE on babies, the investigators will longitudinally track outcomes before and after implementation at Intermountain Healthcare's five NICUs. Process outcomes will include the number of total POKEs per baby and the number of painful POKEs per baby, each measured at both the patient-level and NICU-level. Clinical outcomes will include hospital acquired infections, length of stay, and mortality. Financial outcomes will include total variable costs and backfill rate. The effect of POKE on each of these outcomes will be measured using multivariable regression analysis with appropriate distributional families and interaction terms.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

POKE was developed and implemented at Dixie Regional Medical Center's Neonatal Intensive Care Unit (NICU) over the past 10 years to eliminate waste and reduce harm in healthcare. POKE is a combination of a unique culture and process, with a supporting database, that is designed to guide and inform care decisions while minimizing POKEs. The program utilizes an implementation framework, educational materials, electronic health records (EHR), and decision support analytics. POKE's initial deployment showed extremely promising results for Intermountain, which included: (1) eliminating 11,000 POKEs per year (a 50% reduction in overall POKEs), (2) realizing $940,000 per year in cost savings (a 28% reduction of overall cost), (3) reducing length of stay by 2 weeks per average stay (a 21% reduction in length of stay), and (4) eliminating Hospital Acquired Infections (i.e., Central-line Associated Bloodstream Infection and Ventilator-associated Pneumonia), translating into 10 lives saved and a $5.2M savings over a decade. POKE will now be deployed and routinized within all Intermountain Healthcare NICUs and be developed as a commercial product for external customers. To assess the impact of POKE on babies, the investigators will longitudinally track several outcomes before and after implementation at Intermountain NICUs. Process outcomes will include the number of total POKEs per baby and the number of painful POKEs per baby, each measured at both the patient-level and NICU-level. Clinical outcomes will include hospital acquired infections, length of stay, and mortality. Financial outcomes will include total variable costs and backfill rate.

Study Type

Observational

Enrollment (Anticipated)

2600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center, Intermountain Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Babies admitted to hospital

Description

Inclusion Criteria:

  • All babies in Intermountain Healthcare NICU

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POKE
All babies in NICU at Intermountain Healthcare hospitals
Procedure: There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.
There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of POKEs per baby
Time Frame: 1 October 2018 - 31 May 2019
The primary outcomes will be the number of total POKEs per baby and the number of painful POKEs per baby. We will assess the impact of POKE on each of these outcomes modeled as counts (ie, generalized Poisson distributions) using multivariable regression adjusting for potential confounders including age, gestational age, interaction terms, and nominal indicators of NICU (to account for baseline heterogeneity across sites).
1 October 2018 - 31 May 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Rate
Time Frame: 1 October 2018 - 31 May 2019
Also using multivariable regression, the secondary outcomes will be patient-level indicators, including hospital acquired infection (logistic regression)
1 October 2018 - 31 May 2019
Length of Stay
Time Frame: 1 October 2018 - 31 May 2019
Length of stay (scaled beta regression)
1 October 2018 - 31 May 2019
Mortality
Time Frame: 1 October 2018 - 31 May 2019
Mortality (logistic regression)
1 October 2018 - 31 May 2019
Total Variable Cost
Time Frame: 1 October 2018 - 31 May 2019
Total variable costs (log-linear regression)
1 October 2018 - 31 May 2019
Aggregate Backfill Rate
Time Frame: 1 October 2018 - 31 May 2019
aggregated backfill rate (quasibinomial regression)
1 October 2018 - 31 May 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: R. Erick Ridout, MD, Intermountain Health Care, Inc.
  • Study Director: Terri Kane, RN, MBA, Intermountain Health Care, Inc.
  • Study Director: Brad Isaacson, PhD, MBA, MSF, Intermountain Health Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHC IRB #1050915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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